Guías para compradores de medicamentos procedentes de la India
Explicaciones claras y con fuentes sobre las vías de acceso, los documentos de exportación, la cadena de frío, los pagos y los controles de calidad, para que cada solicitud comience con la vía y la documentación correctas.
Respuesta breve
Estas guías explican cómo los medicamentos de especialidad, huérfanos y sin registro se trasladan legalmente desde la India a hospitales e importadores en el extranjero. Abarcan las vías de acceso, los documentos, las normas de exportación de la India, el envío y el pago, y cada una cita fuentes oficiales y concluye con pasos prácticos.
Comience aquí
Las guías que la mayoría de los compradores leen primero.
- Envío y cadena de frío
Cold-chain shipping of biologics from India
Biologics from India travel in qualified passive shippers or active containers with calibrated data loggers, on a lane whose total time, including customs holds, fits inside the packaging's validated hours. The product's labelled range, set by the manufacturer from stability data, decides the packaging, and every handover should be planned before the goods leave.
6 min de lectura - Ensayos clínicos
Comparator sourcing for clinical trials
A comparator is the authorised product, placebo or standard of care that a trial measures the investigational product against. Sourcing one means matching the market version the protocol and regulators accept, buying from an authorised supply chain, and handing the sponsor's packager unaltered packs with batch, origin and temperature records that support release.
7 min de lectura - Vías de acceso
How named-patient supply works
Named-patient supply is a legal exception that lets a medicine without a local licence reach one identified patient. The treating physician documents the clinical need, a licensed hospital or importer obtains the regulator's approval or files a notification, and the supplier ships to that licensed consignee rather than to the patient's home.
7 min de lectura - Vías de acceso
Importing unlicensed medicines into the UK: MHRA notification and specials
An unlicensed medicine can be imported into the UK only by a WDA(H) or MSL holder that has notified the MHRA, to meet an individual patient's special clinical need under regulation 167. Imports from India normally run through an MSL holder. The goods go to the importer and then a pharmacy, not straight to the patient.
6 min de lectura - Normas de exportación de la India
Indian export rules buyers should know: CDSCO NOCs and shelf life
Medicines not approved in India, new drugs and banned drugs need a CDSCO export NOC before they are made for export, and unexported NOC stock of a formulation can only be reused while it keeps 60 percent of its shelf life. Trading exporters may need a port office NOC, and controlled drugs need an authorisation for each consignment.
6 min de lectura - Documentos
Pharma export documents explained: CoA, COPP, GMP, proforma and packing list
A medicine export from India rests on three sets of papers. Commercial documents cover the proforma, commercial invoice, packing list and air waybill. Quality documents cover the batch certificate of analysis, COPP and GMP certificate. Regulatory documents cover the destination import permit and any Indian export NOC. Each must match the others exactly.
6 min de lectura
Todas las guías
28 guías
- Vías de acceso
Access routes for orphan and rare disease medicines
Orphan designation rewards companies for developing medicines for rare diseases, but it does not make a medicine available in every country. Where an orphan medicine is not registered locally, access usually runs through a named-patient or special access route, an expanded access or compassionate use programme, a clinical trial or an early access scheme.
6 min de lectura - Calidad y seguridad
Avoiding falsified and substandard medicines
Falsified medicines deliberately misrepresent their identity, composition or source, while substandard medicines are authorised products that fail their quality standards or specifications. Buyers lower the risk by sourcing only through licensed channels, asking for traceable batch documents, inspecting packs on arrival and reporting suspect products to the national regulator and the manufacturer.
6 min de lectura - Vías de acceso
Biosimilars and reference biologics in named-patient supply
A biosimilar is highly similar to a reference biologic already approved by a given regulator, but approval in one jurisdiction does not carry over to another. In named-patient supply the prescriber names the product, the supplier does not substitute, and the brand, manufacturer and batch are recorded so that any adverse reaction can be traced.
6 min de lectura - Envío y cadena de frío
Cold-chain shipping of biologics from India
Biologics from India travel in qualified passive shippers or active containers with calibrated data loggers, on a lane whose total time, including customs holds, fits inside the packaging's validated hours. The product's labelled range, set by the manufacturer from stability data, decides the packaging, and every handover should be planned before the goods leave.
6 min de lectura - Ensayos clínicos
Comparator sourcing for clinical trials
A comparator is the authorised product, placebo or standard of care that a trial measures the investigational product against. Sourcing one means matching the market version the protocol and regulators accept, buying from an authorised supply chain, and handing the sponsor's packager unaltered packs with batch, origin and temperature records that support release.
7 min de lectura - Envío y cadena de frío
Courier or air cargo for medicines: how to choose
Courier suits small, urgent, non-controlled parcels that need door-to-door delivery, typically in 3 to 7 days. Air cargo suits larger lots, powered temperature control and all controlled drugs, and typically takes 7 to 15 days including clearance. The destination permit, the temperature band and who must clear customs usually decide the choice.
6 min de lectura - Vías de acceso
Expanded access, compassionate use and named-patient supply compared
Expanded access and compassionate use give patients an investigational medicine from its developer before approval, under a regulator-supervised programme. Named-patient supply lets a licensed local party import a medicine, often already approved in another country, for one patient's clinical need. All three need a treating physician, but legal basis, product status and supply source differ.
6 min de lectura - Vías de acceso
How named-patient supply works
Named-patient supply is a legal exception that lets a medicine without a local licence reach one identified patient. The treating physician documents the clinical need, a licensed hospital or importer obtains the regulator's approval or files a notification, and the supplier ships to that licensed consignee rather than to the patient's home.
7 min de lectura - Pagos y precios
How to pay for an international medicine order: wire transfer and letters of credit
Most international medicine orders from India are paid by SWIFT wire transfer against a proforma invoice, often fully in advance for named-patient and first orders. Larger government and distributor orders may use a letter of credit under the ICC's UCP 600 rules. Indian exporters must currently realise export proceeds within nine months of shipment.
6 min de lectura - Documentos
How to prepare a medicine sourcing request
A good sourcing request names the medicine by INN and, where needed, brand, with strength, form, pack and quantity. It also states the destination country, consignee type, permit status, minimum shelf life, Incoterm and date needed. With those details an exporter can confirm availability, documents and lead time in one reply instead of several.
6 min de lectura - Calidad y seguridad
How to verify a medicine supplier
Verifying a medicine supplier means checking that it holds the licences its role requires, that those licences are current and match its legal name and address, and that every product arrives with traceable manufacturer documents. For a supplier in India, the core checks are the state drug licence, the IEC, GST registration and the product's quality certificates.
6 min de lectura - DocumentosEnvío y cadena de frío
HS codes and customs classification for medicines
Most finished medicines fall in chapter 30 of the Harmonized System. Heading 3004 covers medicaments in measured doses or retail packs, 3003 covers mixed medicaments in bulk, 3002 covers vaccines, blood fractions, immunological products such as monoclonal antibodies and cell therapies, and 3006 covers listed goods such as blinded clinical trial kits.
5 min de lectura - Vías de acceso
Importing unlicensed medicines into the UK: MHRA notification and specials
An unlicensed medicine can be imported into the UK only by a WDA(H) or MSL holder that has notified the MHRA, to meet an individual patient's special clinical need under regulation 167. Imports from India normally run through an MSL holder. The goods go to the importer and then a pharmacy, not straight to the patient.
6 min de lectura - Vías de acceso
Importing unregistered medicines into Latin America: Brazil, Mexico, Colombia and Peru
Brazil, Mexico, Colombia and Peru each allow an unregistered medicine in only through a regulator's exceptional route: ANVISA's hospital import, a COFEPRIS sanitary import permit, INVIMA's vital medicine not available authorisation or a DIGEMID exceptional authorisation. A local hospital, importer or the patient applies before shipment, and review times range from one day to several weeks.
6 min de lectura - Vías de acceso
Importing unregistered medicines into Russia, Kazakhstan and Uzbekistan
Russia and Kazakhstan let an unregistered medicine in for a specific patient only under a Ministry of Health conclusion requested by a local medical organisation or importer, decided within 5 and 3 working days. Uzbekistan relies on a Ministry order or its 2025 list of medicines without registered analogues, followed by mandatory certification.
6 min de lectura - Envío y cadena de fríoPagos y precios
Incoterms for pharmaceutical exports
Incoterms 2020 set who pays for carriage and insurance, who clears customs and where risk passes, but not when payment is due or when ownership passes. For air shipments of medicines only the seven any-mode rules fit, and FCA, CPT, CIP and DAP are the most common, with CIP requiring all-risk cover.
6 min de lectura - Normas de exportación de la India
Indian export rules buyers should know: CDSCO NOCs and shelf life
Medicines not approved in India, new drugs and banned drugs need a CDSCO export NOC before they are made for export, and unexported NOC stock of a formulation can only be reused while it keeps 60 percent of its shelf life. Trading exporters may need a port office NOC, and controlled drugs need an authorisation for each consignment.
6 min de lectura - Pagos y precios
Medicine pricing and lead times explained
A quote for an internationally supplied medicine combines the product cost with regulatory, documentation, packaging, freight, insurance and banking costs, split between buyer and seller by the agreed Incoterm. The lead time adds sourcing time, Indian regulatory time, the destination permit and transit. Each part can be estimated, but few are fixed.
6 min de lectura - Vías de acceso
NAFDAC permits for unregistered medicines in Nigeria
A medicine that is not registered with NAFDAC can enter Nigeria only under a permit issued before shipment. The registration regulations allow permits outside full registration for set purposes, and NAFDAC publishes separate guidelines for donations and controlled drugs. A Nigerian hospital, licensed importer, recipient or trial sponsor applies, not the overseas supplier.
6 min de lectura - Documentos
Pharma export documents explained: CoA, COPP, GMP, proforma and packing list
A medicine export from India rests on three sets of papers. Commercial documents cover the proforma, commercial invoice, packing list and air waybill. Quality documents cover the batch certificate of analysis, COPP and GMP certificate. Regulatory documents cover the destination import permit and any Indian export NOC. Each must match the others exactly.
6 min de lectura - Calidad y seguridadNormas de exportación de la India
Remaining shelf-life requirements in international medicine supply
Many importing countries set a minimum remaining shelf life for medicines on arrival, often as a share of the total shelf life, such as two thirds in Qatar and Egypt or 60 percent in Ghana and Tanzania. India adds its own rule for unexported NOC stock. Buyers should state the requirement up front and check the batch before dispatch.
6 min de lectura - Vías de acceso
SAHPRA Section 21: importing unregistered medicines into South Africa
Section 21 of South Africa's Medicines Act lets SAHPRA authorise the sale of a specified quantity of an unregistered medicine to a specified person or institution for a specified period. The treating practitioner applies online, names a SAHPRA-licensed importer, and the authorisation must be in place before the medicine is imported.
6 min de lectura - Vías de acceso
Sourcing medicines during a shortage
When a registered medicine runs short, a hospital or importer should confirm the shortage on an official list, check whether the regulator has announced an import measure, and use the country's special access route to bring in a foreign-approved product. The prescriber decides on alternatives, and the source and batch must be verifiable.
6 min de lectura - Vías de acceso
Special access routes for unregistered medicines in the GCC
Each Gulf state runs its own route for medicines that are not registered locally. The UAE, Saudi Arabia, Oman and Qatar publish hospital or warehouse routes with prior regulator approval, while Kuwait has no published single-patient procedure. In every case a licensed local party holds the approval before the medicine ships.
6 min de lectura - Envío y cadena de fríoCalidad y seguridad
Temperature excursions in transit: what buyers should do
When a logger shows a temperature excursion, the buyer should keep the goods in correct storage under quarantine, keep the packaging and logger file, notify the supplier and carrier in writing at once, and wait for a documented decision based on the manufacturer's stability data. The stock should not be used or destroyed before that decision.
6 min de lectura - Documentos
What a certificate of pharmaceutical product (COPP) is and when you need one
A certificate of pharmaceutical product (COPP) is a WHO-format certificate, issued by the regulator of the exporting country for a single product, that states whether the product is authorised there and whether its manufacturing site meets WHO good manufacturing practice. Importing regulators use it mainly for registration, and some ask for it for special imports.
6 min de lectura - Calidad y seguridad
What an adverse event report needs
An adverse event report, known as an individual case safety report, is valid only when it has four minimum elements under ICH E2D(R1): an identifiable patient, at least one identifiable reporter, at least one suspect medicinal product and at least one adverse event or reaction. Dates, batch number, seriousness and outcome then make it useful.
6 min de lectura - Licitaciones y ONG
WHO prequalification and donor-funded tenders
Donor-funded buyers such as the Global Fund, UNICEF, PAHO and the Stop TB Global Drug Facility accept only quality-assured products. For HIV, TB and malaria medicines that means WHO prequalification, approval by a stringent or WHO-listed regulator, or a time-limited Expert Review Panel recommendation, plus authorisation in the country of use.
6 min de lectura
Últimas novedades regulatorias
Cambios fechados de autoridades regulatorias y aduanas que afectan a los compradores.
- 25 de octubre de 2026Saudi SFDA updates its SAP guideline for unregistered medicines
- 12 de octubre de 2026CDSCO says approved r-DNA products need no separate export NOC for an export brand
- 1 de octubre de 2026India's FEMA 2026 export rules take effect with a nine-month realisation period
- 1 de octubre de 2026Nhava Sheva extends post facto export NOC relaxation to 31 December 2026
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Costo puesto en destino, documentos, plazo de entrega y controles de cadena de frío, calculados en su navegador.
- Calculadora de costo puesto en destinoMercancía, flete, seguro, aranceles e IVA según cada Incoterm, con quién paga cada concepto.
- Generador de listas de documentosLos documentos que suelen necesitar un país, un tipo de comprador y un producto, listos para imprimir.
- Estimador de plazos de entregaAbastecimiento, controles de exportación en la India, permiso del país de destino y tránsito, sumados.
- Verificador de tránsito en cadena de fríoCompare las horas validadas de un embalaje con el tiempo en el peor escenario de una ruta.
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